At the Biosimilar Medicines Conference in April 2025, Gastón Morán, Director of the Office of Evaluation and Control of Biologicals and Radiopharmaceuticals, highlighted Argentina’s regulatory journey and the institutional pillars sustaining this progress [1].

Argentina’s approach to medicines regulation is rooted in Law 16.463 (1964), implemented through Decree 150/92, which defines the lifecycle of medicinal products — from manufacturing to marketing. Decree 1490/92 established ANMAT as a decentralized authority, bringing together specialized institutes under one umbrella, including: INAME (Drugs), INAL (Food), National Institute of Medical Devices, and the General Administration Directorate.

Within ANMAT, INAME houses the Office of Evaluation and Control of Biologicals and Radiopharmaceuticals, a key department responsible for pre- and post-market evaluation of biologicals. It incorporates the Department of Facility Quality Assurance, the Department of the National Laboratory for Biologicals Control, and the Department of Product Evaluation and Marketing.

An integrated model ensures that both scientific rigour and safety oversight are embedded throughout a product’s lifecycle.

Argentina has issued specific and progressive regulations to handle the complexity of biological and biosimilar products, including Reg. 7729/11 (Establishes the requirements for the registration of biosimilars) and Reg. 741/2025 (Defines the requirements and criteria for the exercise of comparability).

Recently, Argentina promoted local biosimilar production through Decree 1741/2025 to lower treatment costs and reduce import dependence. The measures introduced through Decree 1741/2025 represents an important step toward a more inclusive and sustainable healthcare system in the country [2].

To date, 28 biosimilars have been authorized, highlighting the maturity of the system.

Argentina’s regulatory framework for biosimilars demonstrates how strong institutional design, updated legal instruments, and inter-agency coordination can position a country at the forefront of biological medicine regulation. ANMAT’s evolving model is a reference for regional health authorities aiming to improve access to safe and effective therapies.

Related articles 
Nomenclature of biologicals and biosimilars in Argentina 

Biosimilars as a sustainable option for the health system in Argentina

References
1. Morán, G. (3-4 April 2025). Director of the Office of Evaluation and Control of Biologicals and Radiopharmaceuticals, INAME-ANMAT. Presentation at the Biosimilar Medicines Conference, Brussels, Belgium.
2. GaBI Online - Generics and Biosimilars Initiative. New decree promotes Argentine-made biosimilar medicines[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 22]. Available from: www.gabionline.net/guidelines/new-decree-promotes-argentine-made-biosimilar-medicines

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